Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
AB Science Paris, France (4/2). Reviewed promotional materials for Kinavet-CA1 (masitinib mesylate) at www.kinavet.com and other material submitted to FDA. Misbranded: The materials provide evidence that Kinavet-CA1 is intended for new uses for which it lacks approval, conditional approval or an index listing, and for which its labeling does not provide adequate directions for use. Kinavet-CA1 is approved for treating nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy, except corticosteroids. The firm’s Web site contains the following statement: “The molecular targets of Kinavet-CA1 make it potentially well-suited for treating non-oncology diseases, such as canine atopic dermatitis or feline asthma;…” Also, the Web site and other materials contain no human warning information, etc. (Kinavet-CA1); FDCA 352(a) and (n)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404337.htm
Albert Max Inc., dba Vita Springs Health Chino, CA (6/24). Inspected 5/9-528/13. Unapproved new drugs, misbranded: The firm did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. It did not establish specifications for each component that it uses in the manufacture of the supplements. It also failed to ensure that the tests and examinations it uses to determine whether specifications are met are appropriate scientifically valid methods, etc. (dietary supplements); FDCA 505(a), 403, 21 CFR 111.75(a)(1)(i), 111.75(h)(1), 111.70(b), 111.205(a), 111.210(h)(2), 111.105, 111.110(b), 111.75
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404345.htm
JCB Labs, Inc. Wichita, KS (7/7). Inspected 2/12-27/13. Adulterated: FDA inspected the firm after receiving reports of adverse events in patients who were administered Propoven repackaged by the firm. Investigators noted that the drug products that were intended or expected to be sterile were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated. The firm does not package propofol in tight containers under an atmosphere of inert gas. It also deviated from its established process during the repackaging of propofol 1% by venting the source vial to the pharmacy atmosphere without adequately determining what effects this has on finished drug product quality attributes, etc. (Propoven (propofol) 1% that the facility repackaged from 100 mL vials into 10 mL syringes); FDCA 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404475.htm
Pinnacle Labs International, Inc. Upland, CA (6/19). Inspected 4/11-5/1/13. Misbranded: The firm did not verify that its finished batch of the dietary supplement met product specifications. The quality control personnel did not review and approve the results of identity tests conducted by a contract laboratory on dietary ingredient components prior to their use in the manufacture of dietary supplements, etc. (dietary supplements); FDCA 403(s)(2)(B), 403(y), 403(i)(2), 21 CFR 111.75 (a)(1)(i) & (c), 111.260
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404451.htm
Spinal Elements, Inc. Carlsbad, CA (6/12). Inspected 1/6-15. Adulterated, misbranded: The firm does not have an approved application for a PMA. It is misbranded due to unsubstantiated claims made in the labeling and Web site for the Ti-Bond coating, etc. (Lucent and Lucent Ti-Bond Intervertebral Body Fusion Devices); FDCA 501(f)(1)(B), 502(o), 515(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404513.htm
Trifarma S.p.A. Milano, Italy (7/7). Inspected 1/27-29. GMP deviations, adulterated: The firm deleted all electronic raw data supporting the high performance liquid chromatography testing of all API products released to the U.S. market. Also, the firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. The firm’s lack of data control causes FDA to question the reliability of its data. Its laboratory systems did not have access controls to prevent deletion or alteration of raw data, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404316.htm
Ventlab LLC. Grand Rapids, MI (7/2). Inspected 5/2-6/4. The firm failed to establish and maintain procedures for implementing corrective and preventive action. It also failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. From 2/1/12-May 2013, the firm received and utilized for manufacturing, patient valves containing duckbill valves that did not conform to the specified requirements of being washed, dried and lubricated and these changes in the manufacturing process were not communicated to the firm by the supplier, etc. (Ventlab Manual Resuscitation Bags); FDCA 501(h), 21CFR 820.100(a), 820.198(a), 820.50(a), 820.30(g), 820.90(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm404598.htm
